Various cardiovascular procedures, such as angioplasty, stent placement and atherectomy, require gaining access to the vasculature. Access to the vasculature typically is through the femoral artery and is percutaneous, involving insertion of a needle in the region of the groin to form a track through subcutaneous tissue and to puncture and create an arteriotomy in the femoral artery. A guidewire is then advanced through the needle and into the femoral artery. The needle then is removed. An introducer sheath, which is typically a single lumen catheter with a hemostasis valve on its proximal end, is then advanced over the guidewire, along the track and into the femoral artery. The sheath provides access into the femoral artery, through the arteriotomy, for longer guidewires, catheters or other instrumentalities in order to perform the selected procedure. The hemostasis valve on the introducer sheath is used to prevent extraneous bleed back or to introduce medication into the patient's body.
After the procedure has been completed, the interventional devices are removed and the arteriotomy must be closed. The size of the puncture opening in the artery corresponds to the size of the catheter or percutaneous introducer sheath used, and such devices may typically range in diameter from 5 French for a diagnostic procedure to 6-20 French for a therapeutic procedure. A number of techniques are known to facilitate closure and healing of the arteriotomy. One technique includes application of pressure at the puncture site for a relatively extended length of time. More particularly, compression has traditionally been applied to the puncture site for at least 30-45 minutes for the wound to close naturally after removal of the catheter. Patients are required to remain lying down, essentially motionless and often with a heavy sandbag placed on their upper leg, for several hours to ensure that the bleeding has stopped. The recovery time from the medical procedure may be as little as half of an hour, but the recovery time from the wound can exceed twenty-four hours. Longer recovery times may result in increased expenses, increased patient discomfort, and greater the risk of complications. Other approaches to arteriotomy closure include a compression clamp device, a thrombotic or collagen plug, biological adhesives adapted to seal the arteriotomy, and/or stapling devices.
In addition, medical suturing systems have been proposed to facilitate closure and healing of the arteriotomy and resolve some of the concerns associated with arteriotomy closure after vascular catheterization procedures. FIGS. 1-2 illustrate an exemplary suturing device 100 for suturing arterial vessel walls and other biological tissue. Suturing device 100 is the commercially available SuperStitch™ closure device by Sutura, Inc. of Fountain Valley, Calif. As explained in U.S. Pat. No. 6,117,144 to Nobles et al., herein incorporated by reference in its entirety, suturing device 100 includes extendable/retractable support arms 110, shown in an expanded or deployed configuration in FIGS. 1-2, that are used to hold a suture (not shown in FIGS. 1-2) beyond an outer circumference of a tubular body of the suturing device (and thus beyond the boundaries of the incision/arteriotomy), and extendable/retractable needles 214 (see FIG. 2) that are used to capture the held suture outside the outer circumference. More particularly, suturing device 100 includes a proximal portion 104 having a handle 102 and a distal portion 106 having a tapered distal tip or nosecone 112. An elongated tubular body 108 extends between handle 102 and distal tip 112. Opposing ends of a suture exit from elongated body 108 via a hole or opening 116 formed within distal tip 112 and are removably or temporarily held within openings 228 of support arms 110 (shown in FIG. 2).
In operation, tapered distal tip 112 is advanced through the target arteriotomy and suture arms 110 may be expanded or deployed within the vessel lumen, such that openings 228 of support arms 110 holding the ends of the suture are positioned adjacent to tissue on opposing sides of the arteriotomy. Needles 214 are then distally extended or deployed from corresponding grooves within elongated body 108, piercing and passing through biological tissue to be sutured on opposing sides of the arteriotomy until the distal ends of needles 214 engage the opposing ends of a suture, held within deployed support arms 110. Once the suture ends are captured by needles 214, the needles and captured suture ends are proximally retracted back into elongated body 108. The support arms are collapsed and the device is removed, with the suture ends still captured therein, thereby releasing a segment of the suture within the vessel lumen adjacent to the arteriotomy. The suture ends are pulled and then tied or knotted in order to close the arteriotomy. Handle 102 allows the physician to externally operate support arms 110 and needles 214 inside a blood vessel. In the embodiment depicted, handle 102 has three buttons to actuate three actions: a first action in which support arms 110 are radially deployed to a fully outward position; a second action to distally advance needles 214 and then proximally retract the needles; and a third action in which support arms 110 are returned to a non-deployed state. Embodiments hereof relate to improvements of the suturing device illustrated in FIGS. 1-2.